BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE II

    MDR report key: 3863734 · Received June 10, 2014

    Report

    Report Number
    8030965-2014-10295
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 24, 2014
    Report Date
    May 27, 2014
    Manufacturer
    SYNTHES OBERDORF
    Product Code
    HWE
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE RELIABILITY ENGINEERING EVALUATES THE DEVICE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND OBSERVED THAT IT DID NOT RUN AND HAD NO POWER. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO WEAR FROM NORMAL USE AND SERVICING. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM CANADA THAT DURING AN OPEN REDUCTION INTERNAL FIXATION DISTAL RADIUS SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE SMALL BATTERY DRIVE DEVICE STOPPED WORKING. ACCORDING TO THE REPORT, THE SURGEON WAS DRILLING A SCREW HOLE WITH A CUTTER DEVICE, WHEN THE SMALL BATTERY DRIVE DEVICE STOPPED WORKING. THE SURGEON SWITCHED OUT THE BATTERY PACK, AND OBSERVED THAT THE DEVICE STILL DID NOT FUNCTION. THERE WAS A REPORTED DELAY OF UNDETERMINED DURATION TO THE SURGICAL PROCEDURE. THERE WAS AN IDENTICAL SPARE DEVICE AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT THE PATIENT¿S POST-OPERATIVE CONDITION WAS STABLE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340550 SMALL BATTERY DRIVE II INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE SYNTHES OBERDORF 1003

    Patients

    Seq Age Sex Outcome Treatment
    1 BATTERY PACK